The Food and Drug Administration (FDA) recently released three untitled letters from the Office of In Vitro Diagnostics and Radiological Health (OIR) to clinical laboratories offering direct-to-consumer genetic tests, as well as a report of case studies purporting to provide public health evidence for FDA oversight of all laboratory-developed tests. The three letters allege that the laboratories in question were offering medical devices that required pre-market review by the FDA. The letters came less than two months after a similar letter in late September.

This all demonstrates that the OIR is still actively trying to assert greater control over clinical laboratories generally – and genetic testing in particular – despite recent legislative efforts to limit this authority and the FDA's recent authorisation of a direct-to-consumer genetic test offered by 23andMe.


The three letters – sent to DNA4Life, DNA-Cardiocheck Inc and Interleukin Genetics Inc – all concerned tests intended to identify patients at increased risk for certain medical conditions or drug responses. The September letter to Pathway Genomics Inc alleged that the company's genetic tests for early cancer detection and the blood collection tubes mailed to consumers were medical devices requiring pre-market review.

The FDA has not traditionally regulated laboratory-developed tests (ie, in vitro diagnostics intended for clinical use and designed, manufactured and used within a single laboratory). However, it has long maintained that the unregulated status of laboratory-developed tests is a result of its decision to refrain from invoking its medical device authorities, rather than a consequence of its lack of statutory authority over laboratory-developed tests.

The FDA has taken steps in recent years to assert authority over laboratory-developed tests, particularly direct-to-consumer genetic tests. In 2010 and 2011 the FDA issued at least 20 untitled letters targeting direct-to-consumer genetic tests. In 2014 the FDA further proposed a framework for regulatory oversight of all laboratory-developed tests, which stated that laboratory-developed tests marketed direct to consumers are subject to regulation as medical devices and not eligible for enforcement discretion.(1) On November 16 2015 the FDA Office of Public Health Strategy and Analysis released a report calling for additional oversight of laboratory-developed tests, describing 20 examples of tests that "may have caused or have caused actual harm to patients" due to the absence of compliance with FDA requirements. More than half of the examples involved genetic testing.(2)

A coalition of manufacturers and two physician specialty societies have responded by proposing legislative text that would limit the FDA's authority over laboratory-developed tests; the House of Representatives Committee on Energy and Commerce recently issued a discussion draft of this legislation. 'Precision medicine' proposals, focused on the development of personalised therapies and diagnostics, have also been included in several bills introduced in Congress. Further, the FDA issued a de novo decision letter authorising 23andMe to market genetic carrier tests direct to consumers, after having asked the company to stop marketing those and other genetic tests in a November 2013 warning letter.


Some clinical laboratories seeking to offer direct-to-consumer genetic tests might have viewed previous developments as evidence that the FDA's approach has softened in light of uncertain federal policy. The recent letters and report signal that the FDA remains focused on such tests and willing to assert authority over them.

For further information on this topic please contact Coleen Klasmeier, Torrey Cope or Andrew R Van Haute at Sidley Austin LLP by telephone (+1 202 736 8600) or email (, or The Sidley Austin website can be accessed at


(1) Draft Guidance for Industry, FDA Staff, and Clinical Laboratories: Framework for Regulatory Oversight of LDTs 5 no 4 (FDA, October 3 2014).

(2) The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies (FDA, November 16 2015).

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